Regulations for the control of narcotic drugs in Czechoslovakia

Abstract

The regulations formerly governing State supervision of the storage and distribution of narcotic drugs in Czechoslovakia were Laws Nos. 29/1938 and 137/1938 ( Collection of Laws and Decrees of the Czechoslovak State, No. 9 of 16 February 1938 and No. 45 of 4 July 1938). The laws and regulations have of course had to be modified to take account of the modernization and re-organization of methods of manufacture and distribution of narcotic drugs. On 16 June 1953 the Ministry of Health, in agreement with the Ministry of Food and Agriculture, issued a directive to local national committees laying down new regulations on the subject and rescinding the previous laws.

Details

V. Dr. pharm. Mr. Ph. Ph.D. PARRAK Director of the State Institute for the Control of Medicaments, Bratislava, Czechoslovakiaibt

The regulations formerly governing State supervision of the storage and distribution of narcotic drugs in Czechoslovakia were Laws Nos. 29/1938 and 137/1938 ( Collection of Laws and Decrees of the Czechoslovak State, No. 9 of 16 February 1938 and No. 45 of 4 July 1938). The laws and regulations have of course had to be modified to take account of the modernization and re-organization of methods of manufacture and distribution of narcotic drugs. On 16 June 1953 the Ministry of Health, in agreement with the Ministry of Food and Agriculture, issued a directive to local national committees laying down new regulations on the subject and rescinding the previous laws.

Article 1 of the preamble of this directive lists the narcotic drugs and preparations to which the regulations apply, and these substances are also listed in a schedule annexed to the directive. Articles 2 to 14 set forth the conditions under which these substances may be held and lays down rules for manufacturers and distributors, galenical laboratories, preventive and curative medical services, research and scientific testing institutes and import and export firms.

Title I lays down rules for labelling and packing and makes it compulsory for all holders of narcotic drugs to keep a register. Title II covers in detail the system of control of purchase, manufacture, processing, stocking, transfer and sale of narcotic drugs and also the control of prescriptions for these substances issued to individuals.

Regulations concerning supplies and stocks for distributing firms are set forth in paragraphs 1 to 8 of article 6. This article also deals with the manner of transferring such substances within firms and between them and pharmacies. The date of receipt or delivery of each substance must be recorded in a special register together with the name and address of the supplier or the consignee, the amount of the narcotic drug received or dispatched and any losses. Each operation is assigned a serial number. An inventory must be taken at the end of each month and at the end of each calendar year.

The last article of these regulations deals with the issue of import and export licences. These licences are issued by the Ministry of Health; they authorize import or export, forwarding or storage of narcotic drugs and must specify the individual or firm importing the drugs.

A more recent order of the Ministry of Health (No. 35 of 11 April 1961) deals with the possession of narcotic drugs and revokes the previous Ministry of Health directives No. 283/1953 (No. 316/1953 in Slovakia), " Regulations concerning trade in narcotic drugs ", and No. 21/1957 (No. 18/1957 in Slovakia), governing the prescribing of narcotic drugs in hospital institutions.

Order No. 35, made under Decree No. 72/1960 ( Collection of Laws), comprises 82 articles in all and two annexed schedules listing the narcotic drugs and preparations to which the Order relates.

The Order is divided into eight sections, the last of which revokes the previous Ministry of Health regulations. Article 2 of Title I defines narcotic drugs as poisons within the meaning of Decree No. 23/1955 ( Collection of Laws).

Title III deals with possession and handling of narcotic drugs in pharmaceutical establishments and specifies the procedure and rules to be followed in respect of receipt, dispatch and transfer of narcotic drugs between pharmaceutical establishments and between a pharmaceutical establishment and another Ministry of Health institution.

In accordance with the provisions of article 30, all stocks of drugs must be notified to the Ministry of Health at the end of the year on a special form, and any narcotic drug which has for any reason become unfit for medical use must be entered on the form together with detailed explanations. The Pharmaceutical Division of the Regional Health Institute checks the explanations in the report and should the Institute consider them doubtful or unjustified, it will request a sample of the substance in question to make sure that the case is not in fact one of attempted illicit handling. The sample is taken in accordance with the relevant rules laid down for such operations in pharmacies. The sample is then analysed and checked at the State Institute for Control of Medicaments or in the laboratories of the Regional Institute.

After analysis the sample is kept for one year in the control laboratory. Thereafter any sample which is found to conform with the medical regulations must be returned to the sender by the control laboratory. Samples which do not conform must be destroyed.

As in the case of manufacturing firms, strict controls are applied in galenical laboratories and in drug warehouses. The name and amount of drugs, the name of the supplier, the date of receipt, the use made of the product (name and amount of prepared product), date of dispatch, and address of the pharmacy or other drug warehouse where the product has been delivered, must also appear on the register.

Pharmacies may supply narcotic drugs only against a special order form addressed to them by a public health or veterinary establishment; in all other cases a medical prescription must be provided.

In the case of prescriptions, doctors are required to use a special form for all pharmaceutical products containing any substance to which the regulations apply.

Article 65 stipulates that all prescriptions shall be made out in a counterfoil book in quadruplicate. The original must be attached to the invoice sent to the Public Health Institution, the first copy must be sent with the substance to the person concerned, the second copy must be kept on file by the pharmacy as evidence of dispatch and the third copy must be kept by the prescribing doctor.

Title V, which consists of article 16, deals with orders from veterinary surgeons. Such orders are subject to the same control as those for human medical needs.

As indicated at the beginning of this statement, the Czechoslovak State is aware of the importance for society of strict control of narcotic drugs - which under Czechoslovak law are defined as poisons - and instituted an adequate control system as far back as 1938. In the light of the changing situation the administrative and legislative authorities have introduced new regulations in order to contain as far as possible the social evil of drug abuse and illicit traffic in narcotics.